MAUDE Adverse Event Report: ENCORE MEDICAL L.P. RSP SHOULDER INSTRUMENT; GUIDE, REAMER, BONE TAP, 6.5MM, RSP, SHOULDER

Catalog Number	804-03-008
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	06/29/2018
Type of Reportable Event	Malfunction
Event or Problem Description
Instrument failure - the surgeon was reaming the glenoid over the tap, when the tap broke, leaving the screw thread portion stuck in patient.
Additional Manufacturer Narrative
Part of the instrument was returned on 21- aug-2018.When the reported event occurred the instrument may have been in service for 7.2 years.This event occurred during surgery near the patient.There was not another suitable device available, the incident did cause a 10 minute delay in surgery, however; surgery was completed as intended, there was no risk or adverse event reported and the instrument was inspected prior to surgery and was found to be acceptable.A review of the device history record (dhr) revealed no discrepancies or issues with the manufacturing history of this part.Review of the complaint history indicates to date that 5 complaints have been reported against this lot number.The summary of complaints for the reported instrument part is as follows: 3 for functional, 15 for dull/worn, 1 for locking mechanism damaged, 5 for seized/galled, 4 for threads damaged/galled, 25 for bent, 31 for broke/cracked/damaged, 1 for device cracked/broke, 5 for end of life, and 20 blank.Examination of the returned bone tap shows the threaded tip (not returned) broken off confirming the complaint.The reported condition could possibly be a result of heavy use/misuse/wear and care must be taken to avoid compromising their performance.This event is attributable to damage incurred from prolonged use and through misuse or rough handling which surgical instruments are subjected to.This is not an event associated with a product failure, malfunction or issue.There are no indications that this instrument has a design or material deficiency therefore no containment of inventory is required.

• Brand Name: RSP SHOULDER INSTRUMENT
• Common Device Name: GUIDE, REAMER, BONE TAP, 6.5MM, RSP, SHOULDER
• Manufacturer (Section D): ENCORE MEDICAL L.P.; 9800 metric blvd; austin TX 78758 5445
• MDR Report Key: 7712244
• Report Number: 1644408-2018-00660
• Device Sequence Number: 1065752
• Product Code: FZX
• UDI-Device Identifier: 00888912147842
• UDI-Public: (01)00888912147842
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 804-03-008
• Device Lot Number: 53532L03
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/31/2018
• Initial Date Received by Manufacturer: 06/29/2018
• Supplement Date Received by Manufacturer: 08/31/2018
• Initial Report FDA Received Date: 07/23/2018
• Supplement Report FDA Received Date: 09/04/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 58 YR